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Amitriptyline Pregnancy and Breastfeeding Warnings

Amitriptyline is also known as: Elavil, Endep, Vanatrip

Medically reviewed on July 22, 2016

Amitriptyline Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: C
US FDA pregnancy category: C

Comments:
-Withdrawal symptoms have been reported in neonates whose mothers had taken tricyclic antidepressants during the last trimester of pregnancy.
-Cardiac problems, irritability, respiratory distress, muscle spasms, seizures, and urinary retention have been reported in infants whose mothers received tricyclic antidepressants immediately prior to delivery.
-A pregnancy exposure registry is available.

Animal studies have revealed evidence of reduced pregnancy rates, interference of central monoamine transmission, and ossification delays. Limb deformities and developmental delay have been reported in infants whose mothers had taken this drug during pregnancy. There are no adequate and well-controlled studies in pregnant women.

To monitor maternal-fetal outcomes of pregnant women exposed to antidepressant therapy, a National Pregnancy Registry for Antidepressants has been established. Healthcare providers are encouraged to prospectively register patients. For additional information: https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Amitriptyline Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Yes

Comments:
-The effects in the nursing infant are unknown.
-The American Academy of Pediatrics classifies this drug as an agent whose effects on the nursing infant are unknown but may be of concern.
-The WHO classifies this drug as compatible with breastfeeding in doses up to 150 mg/day.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Elavil (amitriptyline)." Stuart Pharmaceuticals, Wilmington, DE.

References for breastfeeding information

  1. Department of Adolescent and Child Health and Development. UNICEF. World Health Organization "Breastfeeding and maternal medication: recommendations for drugs in the eleventh Who model list of essential drugs. Available from: URL: http://whqlibdoc.who.int/hq/2002/55732.pdf?ua=1" ([2003]):
  2. Briggs GG, Freeman RK. "Drugs in Pregnancy and Lactation. 10th ed." Philadelphia, PA: Wolters Kluwer Health (2015):
  3. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  5. Cerner Multum, Inc. "Australian Product Information." O 0
  6. "Product Information. Elavil (amitriptyline)." Stuart Pharmaceuticals, Wilmington, DE.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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